Exemption for supply by national health service bodies
229.—(1) Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product in accordance with condition A or B by—
(a)the Common Services Agency;
(b)a health authority or special health authority;
(c)an NHS trust;
(d)an NHS foundation trust;
(e)a Primary Care Trust; or
(f)a person who is not a doctor, dentist or person lawfully conducting a retail pharmacy business, where the person supplies the product pursuant to an arrangement with one of the persons specified in paragraphs (a) to (e).
(2) Condition A is that the product is supplied for the purpose of being administered to a person in accordance with the written directions of a doctor, dentist, nurse independent prescriber, optometrist independent prescriber or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).
(3) Condition B is that—
(a)the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”);
(b)the PGD relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied and has effect at the time at which it is supplied;
(c)the PGD contains the particulars specified in Part 1 of Schedule 16;
(d)the PGD is signed on behalf of the person specified in column 2 of the table in Part 2 of that Schedule (“the authorising person”) against the entry in column 1 of that table for the class of person by whom the product is supplied;
(e)the individual who supplies the product—
(i)belongs to one of the classes of individual specified in Part 4 of that Schedule, and
(ii)is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of products under the PGD; and
(f)when the product is supplied, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in relation to it.